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RegChange APK

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The description of RegChange

RegChange is an application for regulatory professionals and employees of the pharmaceutical industry involved in change control processes. With a few clicks, the app classifies an intended change according to EU guidance. The main content is the so-called “Classification Guideline” which gives guidance on the details of the various categories of variations based on the Commission Regulation (EC) No 1234/2008.

Advantages over the printed version of the Guideline are:

1. Simple navigation through the guideline, all conditions and documentation requirements at a glance.
2. Variation classification in a pocket. Answer all classification questions on the spot whether in the coffee corner or in a meeting.
3. Fully indexed change descriptions. A single keyword lists all relevant changes containing the keyword. Keyword search includes common synonyms. CMDh recommendations for classification of unforeseen variations (“Article 5”, “Z-Variations”) included.
4. Regular updates
5. Links to all relevant guidelines and frequently asked questions. Link-out of classified changes to Xendo’s fee calculator for a quick cost estimation.

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RegChange APK Version History
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RegChange 1.0.6 for Android 2.3.4+ APK Download

Version: 1.0.6 (5) for Android 2.3.4+ (Gingerbread MR1, API 10)

Update on: 2016-08-09

Signature: 19d601cfd8a3495f4daa04152d53a4167daf5734 RegChange 1.0.6(5) apk safe verified

APK File SHA1: ad940057b8353ad8e385d1822bfed1a1f2349cf5

What's new: RegChange is sponsored by BPI - Bundesverband der Pharmazeutischen Ind More...

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